Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT04571957
• Collaborator: (none)
• Enrollment: 410
• Location: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 59.1

Study Details

Study Description

Brief Summary

Live donor liver transplantation (LDLT) is the treatment of choice for end-stage liver disease, predominantly in the East, where deceased donor liver transplantation is sparse. In LDLT, donor selection has to be stringent; as the donor safety is thepriority. Live liver donors (LLD) with complex biliary and vascular anatomy are increasingly being accepted for donation with the betterment of technical expertise. One of the commonest reasons for LLD rejection is the hepatic parenchymal abnormality because ofsteatosis and steatohepatitis, which can increase the donor risk. Retrospective analysis of donors with non-alcoholic steatohepatitis(NASH) who were optimized and taken up for major hepatectomy from June 2011 to January 2018will be performed.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Other: No Intervention

Detailed Description

Study Design Aim and Objective -

• Primary objective:

• To study the effect of donor optimization protocol in donors with biopsy proven NASH

• To study thebiochemical (LFTSs & INR) recovery in donors with NASH after major hepatectomy

• To compare their biochemical recovery parameters (LFTs & INR) with that of non NASH donors.

• Secondary objectives:

• To study incidence of NASH among live liver donors

• To study their respective recipients' outcomes

• To study the morbidity among LLDs with NASH after major hepatectomy

Methodology:

• Study population:Patients underwentLDLT from June 2011 to January 2019 at Institute of Liver & Biliary Sciences, New Delhi

• Study design:Retrospective study

• Study period:from June 2011 to January 2019

• Sample size with justification:All consecutive LLDs with at least one year of follow up post-operatively

• Intervention: none

• Monitoring and assessment:none Statistical Analysis:Categorical variables were presented as number (percentage) and were compared using the Chi-square test. Continuous variables were presented as mean (standard deviation, SD) and were compared using Mann-Whitney U Test.

Adverse Effects: None Stopping Rule of Study: None

Expected Outcome of the Project: Adherence to a strict dietary and lifestyle modifications plan will cause histological reversal of NASH and fibrosis in LLDs. Their clinical and biochemical recovery following the major hepatectomy will be similar to that of non-NASH LLDs.

Study Design

• Study Type: Observational
• Actual Enrollment: 410 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Donors with NASH Donors with NASH underwent donor optimization protocol	Other: No Intervention; No Intervention
Donors without NASH Donors without NASH	Other: No Intervention; No Intervention

Outcome Measures

Primary Outcome Measures

1. Effect of donor optimization protocol on body weight in donors with biopsy proven NASH [6 weeks to 3 months]

2. Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH. [6 weeks to 3 months]

3. Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH. [6 weeks to 3 months]

4. Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH. [6 weeks to 3 months]

5. Improvement in Liver Function Test in donors with NASH after major hepatectomy. [Day 0 to Day 7]

6. Improvement in Coagulation Profile in donors with NASH after major hepatectomy. [Day 0 to Day 7]

7. Improvement in Liver Function Test between both the groups [Day 0 to Day 7]

Secondary Outcome Measures

1. Proportion of NASH among live liver donors [Day 0]

2. Morbidity among Live Liver Donors with NASH after major hepatectomy [Day 0 to Day 30]

3. Post Operative complications of recipients in both the groups [Day 0 to day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Live Liver Donors who had undergone major hepatectomy (removal of ≥ 3 liver segments)

Exclusion Criteria:

1. Live Liver Donors who had undergone minor hepatectomy (removal of < 3 liver segments)

2. Live Liver Donors of recipients with acute liver failure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT04571957
• Other Study ID Numbers: ILBS-LIVEDONORS-03
• First Posted: Oct 1, 2020
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Oct 1, 2020